Tension band systems and methods

ABSTRACT

A bone fixation assembly may include an elongate fixation member and a flexible tensioning element. The elongate fixation member may include a central longitudinal axis, a distal portion couplable to a first bone fragment of a bone, and a proximal portion couplable to a second bone fragment of the bone to provide fixation of the second bone fragment relative to the first bone fragment. The flexible tensioning element may be couplable to the proximal and distal portions of the elongate fixation member to secure the elongate fixation member to the bone. The flexible tensioning element may be configured to span a bone fracture intermediate the first bone fragment and the second bone fragment to preload the bone fracture in compression to resist tensile force imparted across the bone fracture, thereby maintaining fixation of the first bone fragment relative to the second bone fragment.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Pat. Application No.17/396,107 filed on Aug. 6, 2021, entitled “Tension Band Systems andMethods”, which claims the benefit of U.S. Provisional Pat. ApplicationSerial No. 63/065,188 filed on Aug. 13, 2020, entitled “Tension BandSystems and Methods”. The foregoing are incorporated by reference asthough set forth herein in their entirety.

TECHNICAL FIELD

The present disclosure relates to surgical implants, systems, andmethods. More specifically, the present disclosure relates to surgicalimplants, systems, and methods related to bone fracture repair.

BACKGROUND

Bone fractures may be reduced and repaired with many different types oforthopedic internal fixation devices, systems, and methods. Two commontypes of orthopedic internal fixation devices include intramedullaryrods and bone plates.

Intramedullary rods and bone plates each have their own particularadvantages and disadvantages. For example, intramedullary rods typicallyrequire smaller incision sites and have less or no prominence incomparison to bone plates. Both of these characteristics may bedesirable from a cosmetic perspective. Intramedullary rods usually causefewer disturbances to surrounding soft tissues (e.g., less/no softtissue stripping/irritation) in comparison to bone plates, reducing therisk of complications that may develop after surgery.

On the other hand, a bone plate may provide better structural integrityfor certain types of bone fractures. In some instances, a bone platesurgical procedure may also be less difficult to perform in comparisonto an intramedullary rod surgical procedure.

In any event, both intramedullary rods and bone plates can be associatedwith many risks, including, but not limited to breaking, bone screwsthat may loosen/pull-out over time, delayed healing/non-unions,infections, subsequent hardware removal issues (e.g., revision surgery)resulting in bone voids that can weaken the bone, etc.

Moreover, certain types of bone fractures may be subject to largetensile or traction forces that tend to “pull apart” a fractured bone,further complicating the bone healing process. Example bone fracturesthat can experience large tensile forces include, but are not limited toclavicle fractures, olecranon fractures, fibula fractures, patellarfractures, malleolar fractures, etc. In such cases, an intramedullaryrod or bone plate alone may not provide an optimal solution for fixationstrength and sustained fracture reduction during the bone healingprocess.

A tension band is another form of orthopedic internal fixation devicethat may be utilized to help resist tensile forces to increase fixation,reduce bone fractures, and help promote the bone healing process.However, a tension band alone may not provide optimal fixation strength,reduction characteristics, and/or bone healing in every scenario.

Accordingly, orthopedic fixation devices, systems, and methods that canprovide improved fixation, reduction, and bone healing would bedesirable.

SUMMARY

The various bone fixation devices, systems, and methods of the presentdisclosure have been developed in response to the present state of theart, and in particular, in response to the problems and needs in the artthat have not yet been fully solved by currently available bone fixationdevices, systems, and methods. In some embodiments, the bone fixationdevices, systems, and methods of the present disclosure may provideimproved fixation, reduction, and healing between bone fragments.

In some embodiments, a bone fixation assembly may include an elongatefixation member and a flexible tensioning element. The elongate fixationmember may include a central longitudinal axis, a first portioncouplable within a first intramedullary canal of a first bone fragmentof a bone, a second portion couplable within a second intramedullarycanal of a second bone fragment of the bone to provide fixation of thesecond bone fragment relative to the first bone fragment, a firsttransverse passageway formed through the first portion of the elongatefixation member, and a second transverse passageway formed through thesecond portion of the elongate fixation member. The flexible tensioningelement may be couplable to the first and second portions of theelongate fixation member to secure the elongate fixation member to thebone. The first transverse passageway may be configured to receive theflexible tensioning element therethrough from a first directiontransverse to the central longitudinal axis of the elongate fixationmember, and the second transverse passageway may be configured toreceive the flexible tensioning element therethrough from a seconddirection transverse to the central longitudinal axis of the elongatefixation member. The flexible tensioning element may be configured tospan a bone fracture intermediate the first bone fragment and the secondbone fragment to preload the bone fracture in compression to resisttensile force imparted across the bone fracture, thereby maintainingfixation of the first bone fragment relative to the second bonefragment.

In some embodiments of the bone fixation assembly, a first end of theflexible tensioning element may be couplable with a second end of theflexible tensioning element to secure the elongate fixation member tothe bone.

In some embodiments of the bone fixation assembly, the flexibletensioning element may include a first tension band couplable to thefirst portion of the elongate fixation member through the firsttransverse passageway, and a second tension band couplable to the secondportion of the elongate fixation member through the second transversepassageway.

In some embodiments of the bone fixation assembly, the first and secondtension bands may be couplable to each other to secure the elongatefixation member to the bone.

In some embodiments of the bone fixation assembly, a first end of thefirst tension band may be couplable with a second end of the secondtension band, and a second end of the first tension band may becouplable with a first end of the second tension band to form acrisscross pattern that spans the bone fracture and secures the elongatefixation member to the bone.

In some embodiments of the bone fixation assembly, a securing elementmay be couplable to the flexible tensioning element and configured toprevent loosening of the flexible tensioning element.

In some embodiments of the bone fixation assembly, a tensioner elementmay be couplable to the flexible tensioning element and configured toimpart a tension force to the flexible tensioning element.

In some embodiments, a bone fixation assembly may include an elongatefixation member and a flexible tensioning element. The elongate fixationmember may include a central longitudinal axis, a distal portioncouplable to a first bone fragment of a bone, and a proximal portioncouplable to a second bone fragment of the bone to provide fixation ofthe second bone fragment relative to the first bone fragment. Theflexible tensioning element may be couplable to the proximal portion andthe distal portion of the elongate fixation member to secure theelongate fixation member to the bone. The flexible tensioning elementmay be configured to span a bone fracture intermediate the first bonefragment and the second bone fragment to preload the bone fracture incompression to resist tensile force imparted across the bone fracture,thereby maintaining fixation of the first bone fragment relative to thesecond bone fragment.

In some embodiments of the bone fixation assembly, a first end of theflexible tensioning element may be couplable with a second end of theflexible tensioning element to secure the elongate fixation member tothe bone.

In some embodiments of the bone fixation assembly, a surface of theelongate fixation member may include one or more channels configured toreceive the flexible tensioning element therein to secure the elongatefixation member to the bone.

In some embodiments of the bone fixation assembly, the flexibletensioning element may include a first tension band couplable to thedistal portion of the elongate fixation member, and a second tensionband couplable to the proximal portion of the elongate fixation memberand to the first tension band to secure the elongate fixation member tothe bone.

In some embodiments of the bone fixation assembly, the elongate fixationmember may include a first transverse passageway formed through thedistal portion of the elongate fixation member. The first transversepassageway may be configured to receive the first tension bandtherethrough from a first direction transverse to the centrallongitudinal axis of the elongate fixation member. The elongate fixationmember may also include a second transverse passageway formed throughthe proximal portion of the elongate fixation member. The secondtransverse passageway may be configured to receive the second tensionband therethrough from a second direction transverse to the centrallongitudinal axis of the elongate fixation member.

In some embodiments of the bone fixation assembly, the elongate fixationmember may include a longitudinal passageway configured to receive theflexible tensioning element therethrough.

In some embodiments of the bone fixation assembly, a securing elementmay be couplable to the flexible tensioning element and configured toprevent loosening of the flexible tensioning element.

In some embodiments of the bone fixation assembly, a tensioner elementmay be couplable to the flexible tensioning element and configured toimpart a tension force to the flexible tensioning element.

In some embodiments, a method of fixing a first bone fragment of a bonerelative to a second bone fragment of the bone may include forming oneor more first bone tunnels in the first bone fragment and forming one ormore second bone tunnels in the second bone fragment. The method mayalso include coupling a first portion of an elongate fixation member tothe first bone fragment and coupling a second portion of the elongatefixation member to the second bone fragment to provide fixation of thesecond bone fragment relative to the first bone fragment. The method mayadditionally include passing a flexible tensioning element through theone or more first bone tunnels and the one or more second bone tunnels,coupling the flexible tensioning element to the first portion of theelongate fixation member and the second portion of the elongate fixationmember to secure the elongate fixation member to the bone, and spanninga bone fracture intermediate the first bone fragment and the second bonefragment with the flexible tensioning element to preload the bonefracture in compression to resist tensile force imparted across the bonefracture, thereby maintaining fixation of the first bone fragmentrelative to the second bone fragment.

In some embodiments of the method, forming the one or more first bonetunnels in the first bone fragment may include at least one of: forminga first transverse bone tunnel in the first bone fragment, and forming afirst longitudinal bone tunnel in a first intramedullary canal of thefirst bone fragment. Likewise, forming the one or more second bonetunnels in the second bone fragment comprises at least one of: forming asecond transverse bone tunnel in the second bone fragment, and forming asecond longitudinal bone tunnel in a second intramedullary canal of thesecond bone fragment.

In some embodiments of the method, coupling the first portion of theelongate fixation member to the first bone fragment may include couplingthe first portion of the elongate fixation member within the firstintramedullary canal of the first bone fragment. Likewise, coupling thesecond portion of the elongate fixation member to the second bonefragment may include coupling the second portion of the elongatefixation member within the second intramedullary canal of the secondbone fragment.

In some embodiments of the method, coupling the first portion of theelongate fixation member to the first bone fragment may include couplingthe first portion of the elongate fixation member to a first surface ofthe first bone fragment. Likewise, coupling the second portion of theelongate fixation member to the second bone fragment may includecoupling the second portion of the elongate fixation member to a secondsurface of the second bone fragment.

In some embodiments, the method may also include coupling a first end ofthe flexible tensioning element with a second end of the flexibletensioning element to secure the elongate fixation member to the bone.

These and other features and advantages of the present disclosure willbecome more fully apparent from the following description and appendedclaims or may be learned by the practice of the devices, systems,methods, and instruments set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the disclosure will become more fully apparentfrom the following description taken in conjunction with theaccompanying drawings. Understanding that these drawings depict onlyexemplary embodiments and are, therefore, not to be considered limitingof the scope of the present disclosure, the exemplary embodiments of thepresent disclosure will be described with additional specificity anddetail through use of the accompanying drawings in which:

FIG. 1A illustrates a perspective side view of a fractured bone withfirst and second bone fragments, according to an example of the presentdisclosure;

FIG. 1B illustrates a perspective side view of a reamer that may beutilized to prepare the intramedullary canals of the bone fragments ofFIG. 1A;

FIG. 1C illustrates a perspective side view of a drill guide that may beutilized to prepare one or more transverse bone tunnels in the bonefragments of FIG. 1A;

FIG. 1D illustrates a perspective side view of the bone fragments ofFIG. 1A with prepared intramedullary canals and transverse bone tunnels;

FIG. 1E illustrates a perspective side view of the bone fragments ofFIG. 1A with retrieval wires inserted through the intramedullary canalsand transverse bone tunnels;

FIG. 1F illustrates a side view of an elongate fixation member withflexible tensioning elements passing through transverse passageways ofthe elongate fixation member, according to another embodiment of thepresent disclosure;

FIG. 1G illustrates a perspective side view of the elongate fixationmember of FIG. 1F inserted into one of the prepared bone fragments ofFIG. 1D with the flexible tensioning elements passing through thetransverse bone tunnels;

FIG. 1H illustrates a perspective side view of FIG. 1G with the elongatefixation member inserted into both bone fragments and the bone fracturereduced;

FIG. 1I illustrates a perspective side view of FIG. 1H with the flexibletensioning elements coupled to each other;

FIG. 1J illustrates a top view of a securing element, according to anembodiment of the present disclosure;

FIG. 1K illustrates a top view of a securing element, according toanother embodiment of the present disclosure;

FIG. 1L illustrates a perspective side view of the securing element ofFIG. 1K coupled to the flexible tensioning elements of FIG. 1J;

FIG. 2A illustrates a perspective side view of a fractured bone andreamer, according to another example of the present disclosure;

FIG. 2B illustrates a perspective side view of the bone of FIG. 2A withprepared intramedullary canals;

FIG. 2C illustrates a side view of an elongate fixation member withflexible tensioning elements passing through a longitudinal passagewayof the elongate fixation member, according to an embodiment of thepresent disclosure;

FIG. 2D illustrates a perspective side view of the bone of FIG. 2B withretrieval wires passing through transverse bone tunnels and the preparedintramedullary canals to retrieve flexible tensioning elements passingthrough the elongate fixation member of FIG. 2C;

FIG. 2E illustrates a perspective side view of the bone of FIG. 2D withthe flexible tensioning elements pulled through the transverse bonetunnels;

FIG. 2F illustrates a perspective side view of the bone of FIG. 2E withthe elongate fixation member inserted into the prepared intramedullarycanal and the flexible tensioning elements coupled to each other;

FIG. 3A illustrates a side view of a fractured bone coupled to a boneplate, according to another example of the present disclosure;

FIG. 3B illustrates a side view of the fractured bone of FIG. 3Aincluding a flexible tensioning element coupled to the bone plate;

FIG. 3C illustrates a top view of fractured bone of FIG. 3B;

FIG. 4A illustrates a perspective side view of a fractured bone withfirst and second bone fragments, according to an example of the presentdisclosure;

FIG. 4B illustrates a perspective side view of a reamer guide that maybe utilized with the bone fragments of FIG. 4A;

FIG. 4C illustrates a perspective side view of a reamer that may beutilized to prepare the intramedullary canals of the bone fragments ofFIG. 4A;

FIG. 4D illustrates a perspective side view of the reamer and reamerguide preparing the intramedullary canal of the first bone fragment ofFIG. 4A;

FIG. 4E illustrates a perspective side view of the reamer and reamerguide preparing the intramedullary canal of the second bone fragment ofFIG. 4A;

FIG. 4F illustrates another perspective side view of the reamer andreamer guide preparing the intramedullary canal of the second bonefragment of FIG. 4A;

FIG. 4G illustrates a perspective side view of a drill guide that may beutilized to prepare transverse bone tunnels through the bone fragmentsof FIG. 4A;

FIG. 4H illustrates a perspective side view of a drill bit that may beutilized to prepare the transverse bone tunnels through the bonefragments of FIG. 4A;

FIG. 4I illustrates a perspective side view of the drill guide and thedrill bit preparing the transverse bone tunnels through the bonefragments of FIG. 4A;

FIG. 4J illustrates a perspective side view of a prepared first bonefragment with flexible tensioning elements passing therethrough;

FIG. 4K illustrates a perspective side view of the prepared first bonefragment shown in FIG. 4J and a prepared second bone fragment with aretrieval wire passing therethrough;

FIG. 4L illustrates a perspective side view of the bone fragments ofFIG. 4K with flexible tensioning elements passing therethrough;

FIG. 4M illustrates a perspective side view of FIG. 4L with the flexibletensioning elements coupled to an elongate fixation member, similar tothat shown in FIG. 8E;

FIG. 4N illustrates a perspective side view of FIG. 4M with the elongatefixation member inserted into the intramedullary canals of the bonefragments;

FIG. 4O illustrates a perspective side view of FIG. 4N with the flexibletensioning elements coupled to each other;

FIG. 5A illustrates a perspective side view of a tap that may beutilized to prepare a threaded intramedullary canal within the bonefragments of FIG. 4A, according to another example of the presentdisclosure;

FIG. 5B illustrates a perspective side view of the prepared first bonefragment shown in FIG. 5A with flexible tensioning elements passingtherethrough;

FIG. 5C illustrates a perspective side view of FIG. 5B with an elongatefixation member, according to another embodiment of the presentdisclosure;

FIG. 5D illustrates a perspective side view of FIG. 5C with a preparedsecond bone fragment and a driver that may be utilized to couple theelongate fixation member to the bone fragments from a lateral approach;

FIG. 5E illustrates a perspective side view of FIG. 5D with the drivercoupled to the elongate fixation member;

FIG. 5F illustrates a perspective side view of FIG. 5E with the elongatefixation member inserted within the intramedullary canals of the bonefragments and the flexible tensioning elements passing through thetransverse bone tunnels;

FIG. 5G illustrates a perspective side view of FIG. 5F with the flexibletensioning elements coupled to each other;

FIG. 5H illustrates another perspective side view of FIG. 5G;

FIG. 6A illustrates a perspective side view of the prepared second bonefragment of FIG. 5D;

FIG. 6B illustrates a perspective side view of FIG. 6A with an elongatefixation member and first and second drivers that may be utilized tocouple the elongate fixation member to the bone fragments from both amedial and a lateral direction, according to another embodiment of thepresent disclosure;

FIG. 6C illustrates a perspective side view of FIG. 6B with the seconddriver inserting the elongate fixation member into the intramedullarycanal of the second bone fragment;

FIG. 6D illustrates a perspective side view of FIG. 6C with the firstdriver inserting the elongate fixation member into the intramedullarycanal of the first bone fragment;

FIG. 6E illustrates a perspective side view of FIG. 6D with the elongatefixation member inserted into the intramedullary canals of the bonefragments and the flexible tensioning elements passing through thetransverse bone tunnels;

FIG. 6F illustrates a perspective side view of FIG. 6E with the flexibletensioning elements coupled to each other;

FIG. 7A illustrates a perspective side view of prepared bone fragmentsand an elongate fixation member, according to another embodiment of thepresent disclosure;

FIG. 7B illustrates a perspective side view of FIG. 7A with the elongatefixation member inserted into the bone fragments and flexible tensioningelements passing through transverse bone tunnels;

FIG. 7C illustrates another perspective side view of FIG. 7B;

FIG. 7D illustrates a perspective side view of FIG. 7C with the flexibletensioning elements coupled to each other;

FIG. 8A illustrates a perspective side view of a drill bit preparing apilot hole in a first bone fragment;

FIG. 8B illustrates a perspective side view of a drill bit preparing apilot hole in a second bone fragment;

FIG. 8C illustrates a perspective side view of a reamer preparing theintramedullary canals of the bone fragments of FIGS. 8A and 8B from alateral approach;

FIG. 8D illustrates a perspective side view of FIG. 8C showing theprepared intramedullary canals;

FIG. 8E illustrates a side view of an elongate fixation member,according to another embodiment of the present disclosure;

FIG. 8F illustrates a perspective side view of FIG. 8D with the elongatefixation member of FIG. 8E being inserted into the bone fragments from alateral approach;

FIG. 8G illustrates a perspective side view of FIG. 8F with an impacttool driving the elongate fixation member into the bone fragments;

FIG. 8H illustrates a perspective side view of FIG. 8G with the elongatefixation member inserted into the bone fragments and flexible tensioningelements coupled to the elongate fixation member;

FIG. 8I illustrates a perspective side view of FIG. 8H with the flexibletensioning elements coupled to each other;

FIG. 8J illustrates a perspective side view of FIG. 8J without flexibletensioning elements;

FIG. 8K illustrates a perspective side view of FIG. 8J with a drill bitforming a transverse bone tunnel through the first bone fragment;

FIG. 8L illustrates a perspective side view of FIG. 8J with a drill bitforming a transverse bone tunnel through the second bone fragment;

FIG. 8M illustrates another perspective side view of the first andsecond bone fragments of FIGS. 8K and 8L;

FIG. 8N illustrates a perspective side view of FIG. 8M with flexibletensioning elements passing through the transverse bone tunnels;

FIG. 8O illustrates a perspective side view of FIG. 8N with the flexibletensioning elements coupled to each other;

FIG. 9A illustrates a perspective side view of an elongate fixationmember including a tensioner element, according to another embodiment ofthe present disclosure;

FIG. 9B illustrates a side view of the elongate fixation member of FIG.9A and a bending tool, according to an embodiment of the presentdisclosure;

FIG. 9C illustrates a side view of FIG. 9B with the bending tool coupledto the elongate fixation member and engaging the tensioner element;

FIG. 9D illustrates a perspective side view FIG. 9C with the elongatefixation member inserted into a fractured bone and a flexible tensioningelement passing through the tensioner element;

FIG. 9E illustrates a perspective side view of FIG. 9D with the bendingtool removed from the elongate fixation member;

FIG. 10A illustrates a side view of an elongate fixation member with anangled cap attached thereto, according to an embodiment of the presentdisclosure;

FIG. 10B illustrates a side view of an elongate fixation member with anangled fastener attached thereto, according to an embodiment of thepresent disclosure;

FIG. 10C illustrates a side view of the elongate fixation member of FIG.10B inserted into a bone;

FIG. 11A illustrates a side view of flared fastener, according to anembodiment of the present disclosure; and

FIG. 11B illustrates a side view of flared cap, according to anembodiment of the present disclosure.

It is to be understood that the drawings are for purposes ofillustrating the concepts of the disclosure and may not be drawn toscale. Furthermore, the drawings illustrate exemplary embodiments and donot represent limitations to the scope of the present disclosure.

DETAILED DESCRIPTION

Exemplary embodiments of the present disclosure will be best understoodby reference to the drawings, wherein like parts are designated by likenumerals throughout. It will be readily understood that the componentsof the present disclosure, as generally described and illustrated in thedrawings, could be arranged, and designed in a wide variety of differentconfigurations. Thus, the following more detailed description of theembodiments of the devices, systems, and methods, as represented in thedrawings, is not intended to limit the scope of the present disclosurebut is merely representative of exemplary embodiments of the presentdisclosure.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments. While the various aspects of theembodiments are presented in the drawings, the drawings are notnecessarily drawn to scale unless specifically indicated.

The terms “coupled” and “couplable” can include components that arecoupled to each other, or that are capable of being coupled to eachother, via integral formation, as well as components that are removablyand/or non-removably coupled/couplable with each other. Two componentsmay be functionally coupled to each other even though they are not indirect contact with each other. The term “abutting” refers to componentsthat may be in direct physical contact with each other, although thecomponents may not necessarily be attached together.

As defined herein, the terms “flexible tensioning element” and “tensionband” can comprise any tensioning element that may be utilized topreload a bone fracture in compression to resist tensile or distractionforces imparted across the bone fracture and maintain fixation/reductionof the bone fracture. Any flexible tensioning element or tension banddescribed herein may include, but is not limited to a wire, a suture, afabric, a strap, a strip, etc. Moreover, any flexible tensioning elementor tension band described herein can comprise any flexible,semi-flexible, semi-rigid, or rigid material, or any combination thereofsuitable for preloading a bone fracture in compression. Additionally,any flexible tensioning element or tension band described herein mayinclude, but is not limited to a metal, an alloy, a plastic, a fiber (orgroup of fibers braided/woven together such as Dacron, etc.), a polymer,an elastomeric material, a flexible laminate, a resin, a film, anadhesive, etc.

Any of the devices, features, instruments, method steps, etc., that aredescribed herein with respect to any particular bone fixation assemblyor procedure may also be utilized in conjunction with (or omitted from)any other bone fixation assembly or that is described or contemplatedherein in any combination.

FIGS. 1A-1L illustrate example devices, instruments, and method stepsfor a bone fixation assembly and procedure, according to an embodimentof the present disclosure.

FIG. 1 illustrates a bone 10 comprising a first bone fragment 1 and asecond bone fragment 2 separated by a bone fracture 3. In someembodiments, the bone 10 may comprise a clavicle bone. However, it willbe understood that the various devices, instruments, and method stepsdescribed herein can be utilized in any combination with each other andfor any type of bone fracture including, but not limited to olecranonfractures, fibula fractures, patellar fractures, malleolar fractures,etc.

FIG. 1B illustrates a first step of some embodiments of the procedure,in which the intramedullary canals of the first and second bonefragments 1, 2 may be prepared with a drill bit or reamer 30. Theintramedullary canals of the first and second bone fragments 1, 2 may bedrilled and/or reamed with any diameter drill bit or reamer to anydesired depth within the intramedullary canal in order to form aprepared intramedullary canal. FIG. 1D illustrates the first and secondbone fragments 1, 2 with prepared intramedullary canals including afirst longitudinal bone tunnel or first intramedullary canal 11, and asecond longitudinal bone tunnel or second intramedullary canal 12.

In some non-limiting embodiments of the procedure, a 4.2 mm diameterdrill bit may be utilized and each intramedullary canal of the first andsecond bone fragments 1, 2 may be drilled and/or reamed to a depth ofabout 3 cm. However, it will be understood that in other embodiments anydiameter size and/or any depth may be utilized, as desired.

Moreover, it will also be understood that in some embodiments of theprocedure the intramedullary canals of the bone fragments may notrequire preparation, such as drilling, reaming, etc. For example, insome embodiments a suitable intramedullary rod may be press-fit and/ortamped into an unprepared intramedullary canal of a bone fragment.

FIG. 1C illustrates a second step of some embodiments of the procedure,in which a drill guide 40 may be utilized to place one or moretransverse bone tunnels through a cortical surface 4 of the bone 10 anddown into the prepared intramedullary canals of the bone fragments witha suitable drill bit (not shown).

In some embodiments, the drill guide 40 may be configured to utilize thereamer 30 as a reference to place a drill guide barrel 41 at a correctlocation along the cortical surface 4 of the bone 10, as shown in FIG.1C. In this manner, the drill guide 40 may utilize the morphology and/ordepth of the prepared intramedullary canals to guide the placement ofthe one or more transverse bone tunnels via the drill guide barrel 41.FIG. 1D illustrates the first and second bone fragments 1, 2 withprepared transverse bone tunnels including one or more first transversebone tunnels 21 and one or more second transverse bone tunnels 22.

FIG. 1E illustrates a third step of some embodiments of the procedure,in which one or more retrieval wires 50 may be placed through the firstand second transverse bone tunnels 21, 22 and out the first and secondintramedullary canals 11, 12. This step (and/or other similar stepsdescribed herein) may be facilitated with any suitable tool. In someembodiments, a magnetic wire retriever (not shown) with one or moremagnets located on a tip of the magnetic wire retriever may be utilized.The magnetic wire retriever may be inserted into a bone tunnel tomagnetically capture a wire and retrieve the wire from the bone tunnel.However, it will be understood that any other tool (or not tool at all)may be utilized to help facilitate the step of threading a flexibletensioning element through a bone tunnel.

FIG. 1F illustrates an elongate fixation member 110, according to anembodiment of the present disclosure. The elongate fixation member 110may generally include a distal portion or first portion 101, a proximalportion or second portion 102, and a central longitudinal axis 103.

In some embodiments, the elongate fixation member 110 may be configuredto couple with at least one flexible tensioning element to secure theelongate fixation member to the bone 10.

In some embodiments, a first end of the flexible tensioning element maybe couplable with a second end of the flexible tensioning element tosecure the elongate fixation member 110 to the bone 10.

In some embodiments, the flexible tensioning element may comprise afirst tension band or a first flexible tensioning element 61, as well asa second tension band or a second flexible tensioning element 62 inorder to secure the elongate fixation member 110 to the bone 10.

In some embodiments, the elongate fixation member 110 may include afirst transverse passageway 106 configured to receive the first flexibletensioning element 61 therethrough from a first direction transverse tothe central longitudinal axis 103 of the elongate fixation member 110.The elongate fixation member 110 may also include a second transversepassageway 107 configured to receive the second flexible tensioningelement 62 therethrough from a second direction transverse to thecentral longitudinal axis 103 of the elongate fixation member 110.

In some embodiments, the first direction and the second direction may besimilar to each other.

In some embodiments, the first direction and the second direction may beopposite from each other.

In some embodiments, the first and second flexible tensioning elements61, 62 may be couplable to each other in order to secure the elongatefixation member 110 to the bone 10.

With reference to FIGS. 1H and 1I, in some embodiments a first end 63 ofthe first flexible tensioning element 61 may be couplable with a secondend 66 of the second flexible tensioning element 62, and a second end 64of the first flexible tensioning element 61 may be couplable with afirst end 65 of the second flexible tensioning element 62 to form acrisscross pattern that spans the bone fracture 3 and secures theelongate fixation member 110 to the bone 10.

In some embodiments, the flexible tensioning elements may be configuredto span the bone fracture 3 intermediate the first bone fragment 1 andthe second bone fragment 2 to preload the bone fracture 3 in compressionto resist tensile force imparted across the bone fracture 3, therebymaintaining fixation of the first bone fragment 1 relative to the secondbone fragment 2.

In some embodiments, the elongate fixation member 110 may comprise anintramedullary rod.

In some embodiments, the elongate fixation member 110 may include agenerally cylindrical shape.

In some embodiments, the elongate fixation member 110 may be solid orsubstantially solid. However, it will also be understood that in someembodiments the elongate fixation member 110 may comprise an at leastpartially hollow interior.

In some embodiments, the elongate fixation member 110 may comprise arigid material to provide rigid fixation of the first and second bonefragments 1, 2 relative to each other.

FIG. 1G illustrates a fourth step of some embodiments of the procedure,in which the one or more retrieval wires 50 shown in FIG. 1E may beutilized to couple with and retrieve the first and second flexibletensioning elements 61, 62 in order to pull the first and secondflexible tensioning elements 61, 62 through the intramedullary canalsand back through the transverse bone tunnels formed in the bonefragments.

FIGS. 1G and 1H illustrate a fifth and sixth step of some embodiments ofthe procedure, in which the elongate fixation member 110 may be insertedinto the prepared intramedullary canals of the first and second bonefragments 1, 2. Specifically, FIG. 1G illustrates the elongate fixationmember 110 inserted into the second bone fragment 2 in a fifth step, andFIG. 1H illustrates the elongate fixation member 110 inserted into boththe first and second bone fragments 1, 2 in a sixth step with the bonefracture 3 reduced.

Thus, in some embodiments the first portion 101 of the elongate fixationmember 110 may be couplable within the first intramedullary canal 11 ofthe first bone fragment 1 of the bone 10, and the second portion 102 ofthe elongate fixation member 110 may be couplable within the secondintramedullary canal 12 of the second bone fragment 2 of the bone 10 toprovide fixation of the second bone fragment 2 relative to the firstbone fragment 1.

In some embodiments, steps four through six discussed above can beperformed together in a partial stepwise manner in order to ensure theflexible tensioning elements remain threaded through the transverse bonetunnels during the procedure. In this manner, initial reduction and/orinitial fixation of the bone fracture 3 may be achieved through eitheror both of: (1) inserting the elongate fixation member 110 into theintramedullary canals of the bone fragments via a press fit; and/or (2)tensioning the flexible tensioning elements in order to draw the bonefragments together to achieve initial reduction and/or initial fixationof the bone fracture 3.

FIG. 1I illustrates a seventh step of some embodiments of the procedure,in which the first and second flexible tensioning elements 61, 62 may bewoven around the bone fracture 3 and secured together. The first andsecond flexible tensioning elements 61, 62 may be configured to span thebone fracture 3 and preload the bone fracture 3 in compression to resisttensile and/or distraction forces imparted across the bone fracture 3,thereby maintaining fixation of the first bone fragment 1 relative tothe second bone fragment 2. In this manner, the bone fracture 3 mayreceive improved fixation and reduction strength by combining theelongate fixation member 110 with the first and second flexibletensioning elements 61, 62.

In some embodiments, the first and second flexible tensioning elements61, 62 may be woven around the bone fracture 3 such that they form acrisscross pattern that spans the bone fracture 3 on a side of the bone10.

In some embodiments, the first and second flexible tensioning elements61, 62 may be woven around the bone fracture 3 such that they form acrisscross pattern that spans the bone fracture 3 on a superior side ofthe bone 10. However, it will also be understood that in otherembodiments the flexible tensioning elements may be woven around thebone fracture 3 to form any suitable pattern and on any side of the bone10 to achieve a desired resistance to tensile and/or distraction forcethat may be imparted across the bone fracture 3.

FIGS. 1J-1L illustrate an eighth step of some embodiments of theprocedure, in which a clamp or securing element may be applied to theflexible tensioning elements to secure flexible tensioning elements inplace and prevent the flexible tensioning elements from loosening overtime.

FIG. 1J illustrates a top view of a first securing element 71, as onenon-limiting example of the present disclosure, that may be utilized tosecure the first and second flexible tensioning elements 61, 62 in placeand prevent the first and second flexible tensioning elements 61, 62from loosening over time. The first securing element 71 may include oneor more attachment features 75 that may be configured to couple with thebone 10 and/or the first and second flexible tensioning elements 61, 62to prevent loosening of the first and second flexible tensioningelements 61, 62 over time.

FIG. 1K illustrates a top view of a second securing element 72, asanother non-limiting example of the present disclosure, that may beutilized to secure the first and second flexible tensioning elements 61,62 in place and prevent the first and second flexible tensioningelements 61, 62 from loosening over time. FIG. 1L illustrates the secondsecuring element 72 of FIG. 1K coupled to the first and second flexibletensioning elements 61, 62 of the bone fixation assembly from FIG. 1I.

In some embodiments, the second securing element 72 may be configured toreceive and/or couple with the crisscross pattern formed by the firstand second flexible tensioning elements 61, 62 to prevent the first andsecond flexible tensioning elements 61, 62 from loosening over time.

In some embodiments, the second securing element 72 may include one ormore holes or channels (not shown) configured to receive the first andsecond flexible tensioning elements 61, 62 therein.

In some embodiments, the first and second flexible tensioning elements61, 62 may be threaded into/through the second securing element 72 viathe holes/channels in order to secure the flexible tensioning elementsin place and prevent the flexible tensioning elements from looseningover time.

In some embodiments, the second securing element 72 may include afastener 76 (e.g., such as a set screw, a screw cap, etc.) and afastener aperture 77 configured to receive the fastener 76 therein. Inthese embodiments, the fastener 76 may removably couple with the secondsecuring element 72 (e.g., via threading or by some other means) and maybe configured to apply a compression force to the first and secondflexible tensioning elements 61, 62 to prevent the first and secondflexible tensioning elements 61, 62 from loosening over time.

In some embodiments, the fastener 76 may also be configured to apply atension force to the first and second flexible tensioning elements 61,62 in order to preload the bone fracture in compression to furtherresist tensile/distraction forces that may be imparted across the bonefracture 3 and provide additional fixation of the first bone fragment 1relative to the second bone fragment 2. For example, the fastener 76 mayinclude one or more prongs (not shown) that may engage with the firstand second flexible tensioning elements 61, 62 as the fastener 76rotates into the fastener aperture 77 via threading or by some othermeans. In this manner, the one or more prongs may also engage with androtate the first and second flexible tensioning elements 61, 62 totighten them up and impart a tension force to the first and secondflexible tensioning elements 61, 62 to preload the bone fracture 3 incompression.

In some embodiments, the flexible tensioning elements may cross eachother on top of the second securing element 72. However, it will also beunderstood that in other embodiments the flexible tensioning elementsmay cross each other within the second securing element 72 and/or underthe second securing element 72.

In some embodiments, one or more bone fasteners 78 may also be utilizedto provide additional tension and/or fixation to the first and secondflexible tensioning elements 61, 62 in order to preload the bonefracture 3 in compression and/or to prevent the first and secondflexible tensioning elements 61, 62 from loosening over time, as shownin FIG. 1L. In these embodiments, the one or more bone fasteners 78 maybe configured to hold the ends of the first and second flexibletensioning elements 61, 62 in place with respect to the first and secondbone fragments 1, 2.

In some embodiments, the one or more bone fasteners 78 may comprise bonescrews configured to couple with the bone 10. The bone screws mayinclude bone screw heads configured to capture and/or hold the first andsecond flexible tensioning elements 61, 62 in order to preload the bonefracture 3 in compression and/or to prevent the first and secondflexible tensioning elements 61, 62 from loosening over time.

FIGS. 2A-2F illustrate example devices, instruments, and method stepsfor a bone fixation assembly and procedure, according to anotherembodiment of the present disclosure.

In some embodiments the bone 10 may comprise a distal or proximal end ofa bone, such as a fractured olecranon process of the ulna, as onenon-limiting example. However, it will be understood that the variousdevices, instruments, and method steps described herein can be utilizedin any combination with each other and for any type of bone fractureincluding, but not limited to clavicle fractures, fibula fractures,patellar fractures, malleolar fractures, olecranon process fractures,etc.

FIG. 2A illustrates a first step of some embodiments of the procedure,in which the intramedullary canals of the first and second bonefragments 1, 2 may be prepared with the reamer 30. The intramedullarycanals of the first and second bone fragments 1, 2 may be drilled and/orreamed with any diameter drill bit or reamer to any desired depth withinthe intramedullary canals. FIG. 2B illustrates the first and second bonefragments 1, 2 with prepared first and second intramedullary canals 11,12.

FIG. 2C illustrates a side view of an elongate fixation member 120,according to another embodiment of the present disclosure. The elongatefixation member 120 may generally include the distal or first portion101, the proximal or second portion 102, and the central longitudinalaxis 103.

In some embodiments, the elongate fixation member 120 may be configuredto couple with at least one flexible tensioning element to secure theelongate fixation member 120 to the bone 10.

In some embodiments, the elongate fixation member 120 may comprise alongitudinal passageway 104 formed through the elongate fixation member120 and configured to receive the at least one flexible tensioningelement therethrough.

In some embodiments, a first end of the at least one flexible tensioningelement may be couplable with a second end of the at least one flexibletensioning element to secure the elongate fixation member 110 to thebone 10.

In some embodiments, the at least one flexible tensioning element maycomprise the first flexible tensioning element 61 and the secondflexible tensioning element 62 to secure the elongate fixation member110 to the bone 10.

In some embodiments, the first and second flexible tensioning elements61, 62 may be couplable to each other in order to secure the elongatefixation member 110 to the bone 10.

In some embodiments, the first end 63 of the first flexible tensioningelement 61 may be couplable with the second end 64 of the first flexibletensioning element 61, and the first end 65 of the second flexibletensioning element 62 may be couplable with the second end 66 of thesecond flexible tensioning element 62 such that the first and secondflexible tensioning elements 61, 62 span the bone fracture 3 and securethe elongate fixation member 120 to the bone 10, as shown in FIG. 2F.

In a second step of some embodiments of the procedure, one or more firsttransverse bone tunnels 21 may be formed in the first bone fragment 1,as can be seen in FIG. 2D. The one or more first transverse bone tunnels21 may intersect the first intramedullary canal 11, as previouslydescribed herein. In some embodiments, one or more second transversebone tunnels (not shown) may also be formed in the second bone fragment2 that may intersect the second intramedullary canal 12. The one or moresecond transverse bone tunnels may be slightly spread apart from eachother in the tip of the fractured olecranon process on either side ofthe second intramedullary canal 12. This will create more distancebetween the first and second flexible tensioning elements 61, 62 whichcan provide more rotational control of the fracture and/or allow thefirst and second flexible tensioning elements 61, 62 to be buriedunderneath soft tissues with a lower profile to avoid prominent and/orpainful protrusion of the first and second flexible tensioning elements61, 62 (e.g., under the skin, muscles, soft tissues, etc.).

FIG. 2D illustrates a third step of some embodiments of the procedure,in which one or more retrieval wires 50 may be placed through the firsttransverse bone tunnels 21 and the first and second intramedullarycanals 11, 12 to retrieve the first and second flexible tensioningelements 61, 62, as previously described herein. FIG. 2E shows the firstand second flexible tensioning elements 61, 62 pulled through the firsttransverse bone tunnels 21.

FIG. 2F illustrates a fourth step of some embodiments of the procedure,in which the elongate fixation member 120 may be inserted into theprepared first and second intramedullary canals 11, 12 of the first andsecond bone fragments 1, 2.

FIG. 2F also illustrates a fifth step of some embodiments of theprocedure, in which the first and second flexible tensioning elements61, 62 may be coupled to each other, woven around the bone fracture 3,and secured together.

In some embodiments, the first and second flexible tensioning elements61, 62 may be additionally secured in place and/or tensioned via any ofthe securing element and/or tensioning element designs described orcontemplated herein.

Thus, the first and second flexible tensioning elements 61, 62 may beconfigured to span the bone fracture 3 and preload the bone fracture incompression to resist tensile and/or distraction forces imparted acrossthe bone fracture 3, thereby maintaining fixation of the first bonefragment 1 relative to the second bone fragment 2. In this manner, thebone fracture 3 may receive improved fixation and reduction strength bycombining the elongate fixation member 120 with the first and secondflexible tensioning elements 61, 62.

As previously discussed, the devices and procedures described herein canbe utilized for bone fractures in other various locations throughout thebody. For example, the procedure for an olecranon process fracture couldbe slightly modified for a different type of bone fracture, such as afractured fibula. In this example, the technique would be similar to theolecranon process, except the surgeon would drill up initially from thetip of the fibula along the lateral ankle, then drill holes past thefracture into the fibulae shaft proximal to the fracture. Then, thesurgeon would pull the device from the tip of the lateral malleolus,through the fracture site, and then secure the flexible tensioningelement as previously discussed.

FIGS. 3A-3C illustrate an example bone fixation assembly and procedurethat utilizes an elongate fixation member 130 comprising a bone plate incombination with a flexible tensioning element 60, according to anotherembodiment of the present disclosure.

In some embodiments, the bone fracture 3 may be provisionally reducedand the elongate fixation member 130 may be secured to cortical surfaces4 of the first and second bone fragments 1, 2 (e.g., via bone screws,not shown) in order to provide initial fixation for the bone fracture 3.In some embodiments, the elongate fixation member 130 may be locatedsuperiorly on the bone 10. However, in other embodiments the elongatefixation member 130 may be placed along any side of the bone 10, and/ormultiple bone plates may be utilized to stabilize the bone fracture 3 onany side of the bone 10.

In some embodiments, first and second transverse bone tunnels 21, 22 maybe drilled through the first and second bone fragments 1, 2. In someembodiments, the first and second transverse bone tunnels 21, 22 may bedrilled through the first and second bone fragments 1, 2 in an anteriorto posterior direction (e.g., for a clavicle bone). In some embodiments,the first and second transverse bone tunnels 21, 22 may be drilledthrough the first and second bone fragments 1, 2 at locations that arepast the proximal and distal portions 101, 102 of the elongate fixationmember 130. However, it will be understood that in other embodiments thefirst and second transverse bone tunnels 21, 22 may not be drilledthrough the first and second bone fragments 1, 2 in any particulardirection, or at any location past the proximal and distal portions 101,102 of the elongate fixation member 130.

In some embodiments, the flexible tensioning element 60 may be threadedthrough the first and second transverse bone tunnels 21, 22 and wovenaround or cinched over the bone fracture 3 such that the flexibletensioning element 60 forms one or more crisscross patterns on top of,within, and/or below the elongate fixation member 130. However, it willalso be understood that in other embodiments the flexible tensioningelement 60 may be woven around the bone fracture 3 to form any suitablepattern on any side of the bone 10 and/or any side of the elongatefixation member 130 to preload the bone fracture 3 in compression andresist tensile/distraction forces imparted across the bone fracture 3.

In some embodiments, the flexible tensioning element 60 may comprise asingle flexible tensioning element.

In some embodiments, the flexible tensioning element 60 may comprise oneor more flexible tensioning elements that may be couplable to eachother, such as the first and second flexible tensioning elements 61, 62previously described herein.

In some embodiments, the elongate fixation member 130 may comprise oneor more grooves (not shown) located on top of, within, or on the bottomof the elongate fixation member 130 that may be configured to receivethe flexible tensioning element 60 therein to achieve a lower overallprofile and reduce the risk of prominence and/or complications due tosoft tissue disturbances.

In some embodiments, the flexible tensioning element 60 may be threadedthrough one or more sleeves (not shown) to prevent the flexibletensioning element 60 from cutting through the bone 10 over time. Theone or more sleeves may be made of any biocompatible material including,but not limited to metals, plastics, PEEK, rubber, silicone, etc.

In some embodiments, the flexible tensioning element 60 may also besecured in place and/or tensioned via one or more third securingelements 73 (see FIG. 3C), which may include any of the securing elementdesigns and/or tensioning element designs described or contemplatedherein.

FIGS. 4A-4O illustrate example devices, instruments, and method stepsfor a bone fixation assembly and surgical procedure that may beperformed from a lateral approach, according to another embodiment ofthe present disclosure.

In some embodiments, the bone 10 illustrated in FIG. 4A may comprise aclavicle bone. However, it will be understood that the various devices,instruments, and method steps described herein may be utilized in anycombination with each other and for any type of bone fracture including,but not limited to olecranon fractures, fibula fractures, patellarfractures, malleolar fractures, etc.

FIGS. 4B-4F illustrate a first step of some embodiments of theprocedure, in which the first and second intramedullary canals 11, 12 ofthe first and second bone fragments 1, 2 may be prepared with a drillbit or reamer 30.

In some embodiments, the reamer 30 may be guided through a reamerpassageway 37 that is formed through a reamer guide 35.

In some embodiments, the reamer guide 35 may also include a referencemember 36 projecting from the reamer guide 35.

In some embodiments, the reference member 36 may be configured to abut acortical surface 4 of the first and/or second bone fragments 1, 2 toorient the reamer passageway 37 with respect to the cortical surfaces 4of the first and/or second bone fragments 1, 2.

As previously discussed, the first and second intramedullary canals 11,12 of the first and second bone fragments 1, 2 may be drilled and/orreamed with any diameter drill bit or reamer to any desired depth withinthe intramedullary canal in order to form prepared intramedullarycanals. Moreover, it will also be understood that in some embodiments ofthe procedure the intramedullary canals of the bone fragments may notrequire preparation, such as drilling, reaming, etc. For example, insome embodiments a suitable elongate fixation member may be press-fitand/or tamped into an unprepared intramedullary canal of a bonefragment.

FIGS. 4G-4I illustrate a second step of some embodiments of theprocedure, in which a drill guide 45 and drill bit 31 may be utilized toplace one or more first transverse bone tunnels 21 through the corticalsurface 4 of the first bone fragment 1 down into the prepared firstintramedullary canal 11.

In some embodiments, the drill guide 45 may include one or more drillguide barrels 46, an insert member 47, and a handle 48.

In some embodiments, the insert member 47 may be inserted into theprepared first intramedullary canal 11 to orient the one or more drillguide barrels 46 with respect to the prepared first intramedullary canal11 of the first bone fragment 1.

FIGS. 4J-4L illustrate a third step of some embodiments of theprocedure, in which a retrieval wire 50 may be placed through the secondintramedullary canal 12 of the second bone fragment 2 in order tocapture and pull the first flexible tensioning elements 61 through thesecond intramedullary canal 12 of the second bone fragment 2, as shownin FIG. 4L.

FIG. 4M illustrates a fourth step of some embodiments of the procedure,in which one of the first flexible tensioning elements 61 may be passedthrough the first transverse passageway 106 of the elongate fixationmember 180 and then coupled to the other one of the first flexibletensioning elements 61, as can be seen in FIG. 4M. The elongate fixationmember 180 will be discussed in more detail below with respect to FIG.8E.

FIG. 4N illustrates a fifth step of some embodiments of the procedure,in which the elongate fixation member 180 may be inserted into theprepared first and second intramedullary canals 11, 12 of the first andsecond bone fragments 1, 2 from a lateral approach. This may beaccomplished by pulling the first flexible tensioning elements 61through the first transverse bone tunnels 21, and/or by impacting thedistal end of the elongate fixation member 180 with an impact driver(not shown).

FIG. 4O illustrates a sixth step of some embodiments of the procedure,in which the first and second flexible tensioning elements 61, 62 may bewoven around the bone fracture 3 and secured together, as previouslydescribed herein. The first and second flexible tensioning elements 61,62 may be configured to span the bone fracture 3 and preload the bonefracture 3 in compression to resist tensile and/or distraction forcesimparted across the bone fracture 3, thereby maintaining fixation of thefirst bone fragment 1 relative to the second bone fragment 2. In thismanner, the bone fracture 3 may receive improved fixation and reductionstrength by combining the elongate fixation member 180 with the firstand second flexible tensioning elements 61, 62.

In some embodiments, the first and second flexible tensioning elements61, 62 may also be secured in place and/or tensioned via one or morefourth securing elements 74 (see FIG. 4O), which may include any of thesecuring element designs and/or tensioning element designs described orcontemplated herein.

FIGS. 5A-5H illustrate example devices, instruments, and method stepsfor a bone fixation assembly and surgical procedure that may beperformed from a lateral approach, according to another embodiment ofthe present disclosure.

In some embodiments, the first and second bone fragments 1, 2 may beprepared in a similar manner to the first bone fragment 1 shown in FIGS.4A-4I in a first step and a second step. However, the first and secondintramedullary canals 11, 12 of the first and second bone fragments 1, 2may also be tapped with a tap tool 80 in a third step to form internalbone threads 81 within the first and second intramedullary canals 11, 12(e.g., see FIG. 5A).

FIGS. 5B-5D illustrate a fourth step of some embodiments of theprocedure, in which the first and second flexible tensioning elements61, 62 may be pulled through the bone tunnels of the first bone fragment1, the longitudinal passageway 104 of the elongate fixation member 150,and the second intramedullary canal 12 of the second bone fragment 2 viaa retrieval wire (not shown) in FIGS. 5B-5D.

The elongate fixation member 150 may generally include a distal or firstportion 101, a proximal or second portion 102, a central longitudinalaxis 103, a longitudinal passageway 104, a first thread 151, a secondthread 152, an intermediate portion 153, and a torque reception feature154.

In some embodiments, the elongate fixation member 150 may comprise acompression screw design.

In some embodiments, the first thread 151 may comprise a first pitch,and the second thread 152 may comprise a second pitch that is differentfrom the first pitch of the first thread 151. In these embodiments, thefirst and second bone fragments 1, 2 may be drawn toward each other incompression as the elongate fixation member 150 is inserted into thefirst and second intramedullary canals 11, 12, due to the differentialthread pitches between the first and second threads 151, 152.

In some embodiments, the elongate fixation member 150 (and/or any otherelongate fixation member described or contemplated herein) may comprisea resorbable material (such as PEEK, hydroxyapatite, etc.), and/or anyother biocompatible material such as titanium, stainless steel, polymer,etc.

FIGS. 5D-5F illustrate a fifth step of some embodiments of theprocedure, in which the elongate fixation member 150 may be insertedinto the first and second intramedullary canals 11, 12 of the first andsecond bone fragments 1, 2 from a lateral approach.

FIGS. 5D and 5E illustrate a driver 90 that may be utilized to couplethe elongate fixation member 150 to the first and second bone fragments1, 2. In some embodiments, the driver 90 may include a torquetransmission feature 94 that may be configured to mate with acomplementary shaped torque reception feature 154 formed within thelongitudinal passageway 104 of the elongate fixation member 150 to drivethe elongate fixation member 150 into the first and secondintramedullary canals 11, 12 of the first and second bone fragments 1,2. FIG. 5F shows the elongate fixation member 150 after it has beenfully inserted into the first and second intramedullary canals 11, 12and the bone fracture 3 has been reduced in compression by thecompression screw design of the elongate fixation member 150.

FIG. 5F also illustrates a sixth step of some embodiments of theprocedure, in which the first and second flexible tensioning elements61, 62 may be pulled through the second transverse bone tunnels 22 ofthe second bone fragment 2 after the driver 90 is removed. This may beaccomplished with one or more retrieval wires, as previously discussed.

FIGS. 5G and 5H illustrate a seventh step of some embodiments of theprocedure, in which the first and second flexible tensioning elements61, 62 may be coupled to each other and woven around the bone fracture 3to further preload the bone fracture 3 in compression to resisttensile/distraction forces that may be imparted across the bone fracture3, as previously described. Thus, combining the elongate fixation member150 with the first and second flexible tensioning elements 61, 62provides additional fixation, stabilization, and reduction of the bonefracture 3 over an elongate fixation member or flexible tensioningelement alone.

In some embodiments, the first and second flexible tensioning elements61, 62 may also be secured in place and/or tensioned via one or morefourth securing elements 74, which may include any of the securingelement designs and/or tensioning element designs described orcontemplated herein.

FIGS. 6A-6F illustrate example devices, instruments, and method stepsfor a bone fixation assembly and surgical procedure that may beperformed from both a medial and lateral approach, according to anotherembodiment of the present disclosure.

In some embodiments, the first and second bone fragments 1, 2 may beprepared in a similar manner to the first bone fragment 1 shown in FIGS.4A-4I in a first step and a second step. However, the first and secondintramedullary canals 11, 12 of the first and second bone fragments 1, 2may also be tapped with the tap tool 80 shown in FIG. 5A in a third stepto form internal bone threads 81 within the first and secondintramedullary canals 11, 12.

FIGS. 6A and 6B illustrate a fourth step of some embodiments of theprocedure, in which the first and second flexible tensioning elements61, 62 may be pulled through a first driver 91, the secondintramedullary canal 12 of the second bone fragment 2, the elongatefixation member 150, and a second driver 92. This may be accomplishedwith one or more retrieval wires, as previously discussed.

FIG. 6C illustrates a fifth step of some embodiments of the procedure,in which the second driver 92 may be utilized to drive the elongatefixation member 150 into the second intramedullary canal 12 of thesecond bone fragment 2 from a medial direction.

FIG. 6D illustrates a sixth step of some embodiments of the procedure,in which the first bone fragment 1 may be positioned adjacent the secondbone fragment 2 and the first driver 91 may be utilized to drive theelongate fixation member 150 into the first intramedullary canal 11 ofthe first bone fragment 1 from a lateral direction in order to couplethe elongate fixation member 150 to the first and second bone fragments1, 2.

FIG. 6E illustrates a seventh step of some embodiments of the procedure,in which the first and second flexible tensioning elements 61, 62 may bepulled through the first and second transverse bone tunnels 21, 22 ofthe bone fragments after the first and second drivers 91, 92 have beenremoved. This may be accomplished with one or more retrieval wires, aspreviously discussed.

FIG. 6F illustrates an eighth step of some embodiments of the procedure,in which the first and second flexible tensioning elements 61, 62 may becoupled to each other and woven around the bone fracture 3 to preloadthe bone fracture 3 in compression to further resist tensile/distractionforces that may be imparted across the bone fracture 3, as previouslydescribed. Thus, combining the elongate fixation member 150 with thefirst and second flexible tensioning elements 61, 62 provides additionalfixation, stabilization, and reduction of the bone fracture 3 over anelongate fixation member or flexible tensioning element alone.

In some embodiments, the first and second flexible tensioning elements61, 62 may also be secured in place and/or tensioned via one or moresecuring elements (not shown), which may include any of the securingelement designs and/or tensioning element designs described orcontemplated herein.

FIGS. 7A-7D illustrate example devices, instruments, and method stepsfor a bone fixation assembly and surgical procedure, according toanother embodiment of the present disclosure.

In some embodiments, the first and second bone fragments 1, 2 may beprepared in a similar manner to the first and second bone fragments 1, 2shown in FIGS. 1B-1D in a first step and a second step.

FIG. 7A illustrates a third step of some embodiments of the procedure,in which the first and second flexible tensioning elements 61, 62 may bepassed through a centrally located transverse passageway 175 of anelongate fixation member 170, through the first and secondintramedullary canals 11, 12, and out of the first and second transversebone tunnels 21, 22. This may be accomplished with one or more retrievalwires, as previously discussed.

In some embodiments, the elongate fixation member 170 may include one ormore grooves 176 formed in opposing sides of the elongate fixationmember 170. The one or more grooves 176 may be configured to receive thefirst and second flexible tensioning elements 61, 62 therein tofacilitate insertion of the elongate fixation member 170 into the firstand second intramedullary canals 11, 12 by preventing frictional bindingof the first and second flexible tensioning elements 61, 62 against thewalls of the first and second intramedullary canals 11, 12.

FIGS. 7B and 7C illustrate a fourth step of some embodiments of theprocedure, in which the elongate fixation member 170 may be insertedinto the first and second intramedullary canals 11, 12 of the first andsecond bone fragments 1, 2 reducing the bone fracture 3.

FIG. 7D illustrates a fifth step of some embodiments of the procedure,in which the first and second flexible tensioning elements 61, 62 may becoupled to each other and woven around the bone fracture 3 to preloadthe bone fracture 3 in compression to further resist tensile/distractionforces that may be imparted across the bone fracture 3, as previouslydescribed. Thus, combining the elongate fixation member 170 with thefirst and second flexible tensioning elements 61, 62 provides additionalfixation, stabilization, and reduction of the bone fracture 3 over anelongate fixation member or flexible tensioning element alone.

In some embodiments, the first and second flexible tensioning elements61, 62 may also be secured in place and/or tensioned via one or morefourth securing elements 74, which may include any of the securingelement designs and/or tensioning element designs described orcontemplated herein.

FIGS. 8A-8O illustrate example devices, instruments, and method stepsfor a bone fixation assembly and one or more simplified surgicalprocedures, according to embodiments of the present disclosure.

FIGS. 8A and 8B illustrate a first step of some embodiments of asimplified procedure, in which a drill bit 31 may be utilized to createpilot holes through the first and second intramedullary canals 11, 12 ofthe first and second bone fragments 1, 2.

FIGS. 8C and 8D illustrate a second step of some embodiments of thesimplified procedure, in which the first and second bone fragments 1, 2may be aligned with each other to reduce the bone fracture 3 and areamer 30 may then be utilized to enlarge or ream out the pilot holes ofFIGS. 8A and 8B in order to create prepared first and secondintramedullary canals 11, 12 that are aligned with each other. In someembodiments, the reamer 30 may be utilized from a lateral direction.However, it will be understood that in other embodiments the reamer 30may be utilized from a medial direction.

FIG. 8E illustrates an elongate fixation member 180, according toanother embodiment of the present disclosure. The elongate fixationmember 180 may generally include a distal portion or first portion 101,a proximal portion or second portion 102, and a central longitudinalaxis 103.

In some embodiments, the proximal and/or distal portions 101, 102 maycomprise tapered ends 181 to facilitate insertion of the elongatefixation member 180 into bone.

In some embodiments, the elongate fixation member 180 may include afirst transverse passageway 106 configured to receive a first flexibletensioning element 61 therethrough from a first direction that may betransverse to the central longitudinal axis 103 of the elongate fixationmember 180. The elongate fixation member 180 may also include a secondtransverse passageway 107 configured to receive a second flexibletensioning element 62 therethrough from a second direction that may betransverse to the central longitudinal axis 103 of the elongate fixationmember 180.

In some embodiments, the first direction and the second direction may bethe same, or similar to each other.

In some embodiments, the first direction and the second direction may beopposite from each other.

In some embodiments, the elongate fixation member 180 may comprise anintramedullary rod.

In some embodiments, the elongate fixation member 180 may include agenerally cylindrical shape.

In some embodiments, the elongate fixation member 180 may be solid orsubstantially solid. However, it will also be understood that in someembodiments the elongate fixation member 180 may comprise an at leastpartially hollow interior.

In some embodiments, the elongate fixation member 180 may comprise arigid material to provide rigid fixation of the first and second bonefragments 1, 2 relative to each other.

FIGS. 8F-8H illustrate a third step of some embodiments of thesimplified procedure, in which the elongate fixation member 180 may beinserted into the first and second intramedullary canals 11, 12 of thefirst and second bone fragments 1, 2. FIG. 8F shows the first flexibletensioning element 61 passing through the first and secondintramedullary canals 11, 12. This may be accomplished with one or moreretrieval wires, as previously discussed. FIG. 8G shows the elongatefixation member 180 being forced into the first and secondintramedullary canals 11, 12 with an impact driver tool 93, and FIG. 8Hshows the elongate fixation member 180 placed within the first andsecond intramedullary canals 11, 12.

FIG. 8I illustrates a fourth step of some embodiments of the simplifiedprocedure, in which the first and second flexible tensioning elements61, 62 may be woven around the bone fracture 3 and secured together. Thefirst and second flexible tensioning elements 61, 62 may be configuredto span the bone fracture 3 and preload the bone fracture 3 incompression to resist tensile and/or distraction forces imparted acrossthe bone fracture 3, thereby maintaining fixation of the first bonefragment 1 relative to the second bone fragment 2. In this manner, thebone fracture 3 may receive improved fixation and reduction strength bycombining the elongate fixation member 180 with the first and secondflexible tensioning elements 61, 62.

In some embodiments, the first and second flexible tensioning elements61, 62 may also be secured in place and/or tensioned via one or morefourth securing elements 74, which may include any of the securingelement designs and/or tensioning element designs described orcontemplated herein.

FIGS. 8J-8O illustrate example devices, instruments, and method stepsfor a bone fixation assembly and an alternative simplified surgicalprocedure, according to another embodiment of the present disclosure.

In some embodiments, the first and second bone fragments 1, 2 may beprepared in a similar manner to the first and second bone fragments 1, 2shown in FIGS. 8A-8D in a first step and a second step.

FIG. 8J illustrates a third step of some embodiments of the alternativesimplified procedure, in which the elongate fixation member 180 may beinserted into the first and second intramedullary canals 11, 12 of thefirst and second bone fragments 1, 2 without the first and secondflexible tensioning elements 61, 62 being coupled to the elongatefixation member 180.

FIGS. 8K-8M illustrate a fourth step of some embodiments of thealternative simplified procedure, in which the first and secondtransverse bone tunnels 21, 22 may be formed through the first andsecond bone fragments 1, 2 with a drill bit 31.

In some embodiments, the first and second transverse passageways 106,107 of the elongate fixation member 180 may be utilized to guide thedrill bit 31 through the first and second bone fragments 1, 2 to quicklyform the first and second transverse bone tunnels 21, 22 therethrough.

FIG. 8N illustrates a fifth step of some embodiments of the alternativesimplified procedure, in which the first and second flexible tensioningelements 61, 62 may be inserted through the first and second transversebone tunnels 21, 22 and through the first and second transversepassageways 106, 107 of the elongate fixation member 180.

FIG. 8O illustrates a sixth step of some embodiments of the alternativesimplified procedure, in which the first and second flexible tensioningelements 61, 62 may be woven around the bone fracture 3 and securedtogether. The first and second flexible tensioning elements 61, 62 maybe configured to span the bone fracture 3 and preload the bone fracture3 in compression to resist tensile and/or distraction forces impartedacross the bone fracture 3, thereby maintaining fixation of the firstbone fragment 1 relative to the second bone fragment 2. In this manner,the bone fracture 3 may receive improved fixation and reduction strengthby combining the elongate fixation member 180 with the first and secondflexible tensioning elements 61, 62.

In some embodiments, the first and second flexible tensioning elements61, 62 may also be secured in place and/or tensioned via one or moresecuring elements (not shown), which may include any of the securingelement designs and/or tensioning element designs described orcontemplated herein.

FIGS. 9A-9E illustrate example devices, instruments, and method stepsfor a bone fixation assembly and procedure, according to anotherembodiment of the present disclosure.

FIG. 9A illustrates an elongate fixation member 190 couplable with atensioner element 195, according to an embodiment of the presentdisclosure.

The elongate fixation member 190 may include a distal or first portion101, a proximal or second portion 102, an eyelet 199 at the distalportion, one or more attachment features 197, and a recess 194 formed inthe proximal portion of the elongate fixation member 190.

The tensioner element 195 may include an attachment member 196, aresilient member 193, and an opening 198 formed in the resilient member193.

In some embodiments, the resilient member 193 may be slightly angledwith respect to the attachment member 196 in a free state.

In some embodiments, the tensioner element 195 may comprise a superelastic material (e.g., such as nitinol, etc.) that may be configured toprovide a tensioning force to the flexible tensioning element 60, asshown in FIGS. 9D and 9E.

In some embodiments, the attachment member 196 may be received withinthe recess 194 formed in the proximal portion of the elongate fixationmember 190 to removably couple the tensioner element 195 with theelongate fixation member 190.

In some embodiments, the tensioner element 195 may be integrally formedwith, or otherwise permanently attached to, the elongate fixation member190.

In some embodiments, the elongate fixation member 190 may comprise aresorbable material (such as PEEK, hydroxyapatite, etc.) and/or anyother biocompatible material such as titanium, stainless steel, polymer,etc.

FIGS. 9B and 9C illustrate the elongate fixation member 190 of FIG. 9Ain conjunction with an actuation tool 210, according to an embodiment ofthe present disclosure.

In some embodiments, the actuation tool 210 may include an actuator 211coupled with a handle 212.

In some embodiments, the actuation tool 210 may also include one or moreattachment features (not shown) which may be configured to engage withthe one or more attachment features 197 of the elongate fixation member190 to removably couple the actuation tool 210 with the elongatefixation member 190, as shown in FIGS. 9C and 9D.

In some embodiments, the actuator 211 may comprise a threaded thumbscrew which may be advanced toward the resilient member 193 via rotationin a first direction to bend the resilient member 193 forward, as shownin FIGS. 9C and 9D.

In some embodiments, the resilient member 193 of the tensioner element195 may be bent to about 90 degrees when fully loaded by the actuator211.

In some embodiments, the actuator 211 may be retracted from theresilient member 193 via rotation in a second direction to release theresilient member 193 and/or remove the actuation tool 210 from theelongate fixation member 190, as shown in FIGS. 9B and 9E.

FIG. 9D illustrates the elongate fixation member 190 inserted into abone 10 and a flexible tensioning element 60 passing through the opening198 in the resilient member 193 with the actuation tool 210 attached tothe elongate fixation member 190 and applying a bending force to theresilient member 193. In this manner, the surgeon can couple theflexible tensioning element 60 to the resilient member 193 as tight aspossible while the resilient member 193 is bent forward by the actuator211.

FIG. 9E illustrates the bone fixation assembly of FIG. 9D with theactuation tool 210 removed from the elongate fixation member 190, thusallowing the resilient member 193 to pull the flexible tensioningelement 60 even tighter and further preload the bone fracture 3 incompression to resist tensile/distraction forces that may be impartedacross the bone fracture 3, as previously described.

FIGS. 10A-11B illustrate various alternative devices and methods fortensioning a flexible tensioning element, according to embodiments ofthe present disclosure.

FIG. 10A illustrates an elongate fixation member 200 with an angled cap220 attached thereto at an angle with respect to the elongate fixationmember 200. In this embodiment, a bottom surface 221 of the angled cap220 may act to press downward on a flexible tensioning element (notshown) that may be coupled to the bottom surface 221 of the angled cap220. This may further tension the flexible tensioning element andpreload a bone fracture in compression to resist tensile/distractionforces that may be imparted across the bone fracture, as previouslydescribed herein.

FIG. 10B illustrates an elongate fixation member 201 with an angledfastener 230 attached thereto at an angle with respect to the elongatefixation member 201. In this embodiment, a bottom surface 231 of theangled fastener 230 may likewise act to press downward on a flexibletensioning element (not shown) that may be coupled to the bottom surface231 of the angled fastener 230. This may further tension the flexibletensioning element and preload a bone fracture in compression to resisttensile/distraction forces that may be imparted across the bonefracture, as previously described herein. FIG. 10C illustrates theelongate fixation member 201 and the angled fastener 230 inserted into abone 10.

FIG. 11A illustrates a flared fastener 240 comprising a flared portion241 near the head of the flared fastener 240. In this manner, the flaredfastener 240 may be coupled with an elongate fixation member (not shown)without the need of angling the flared fastener 240 with respect to theelongate fixation member, due to the inherent angle already created bythe flared portion 241. In this embodiment, the flared portion 241 mayact to press on a flexible tensioning element (not shown) as the flaredfastener 240 couples with an elongate fixation member. This may furthertension the flexible tensioning element and preload a bone fracture incompression to resist tensile/distraction forces that may be impartedacross the bone fracture, as previously described herein.

FIG. 11B illustrates a flared cap 250 comprising a flared portion 251near the head of the flared cap 250. In this manner, the flared cap 250may likewise be coupled with an elongate fixation member (not shown)without the need of angling the flared cap 250 with respect to theelongate fixation member, due to the inherent angle already created bythe flared portion 251. In this embodiment, the flared portion 251 maylikewise act to press on a flexible tensioning element (not shown) asthe flared cap 250 couples with an elongate fixation member. This mayfurther tension the flexible tensioning element and preload a bonefracture in compression to resist tensile/distraction forces that may beimparted across the bone fracture, as previously described herein.

Any procedures or methods disclosed herein may comprise one or moresteps or actions for performing the described procedures or methods. Themethod steps and/or actions may be interchanged with one another. Inother words, unless a specific order of steps or actions is required forproper operation of the embodiment, the order and/or use of specificsteps and/or actions may be modified.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure, orcharacteristic described in connection with that embodiment is includedin at least one embodiment. Thus, the quoted phrases, or variationsthereof, as recited throughout this specification are not necessarilyall referring to the same embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, drawing, or description thereof for the purpose ofstreamlining the present disclosure. This method of disclosure, however,is not to be interpreted as reflecting an intention that any embodimentrequires more features than those expressly recited in that embodiment.Rather, inventive aspects lie in a combination of fewer than allfeatures of any single embodiment disclosed herein.

Recitation of the term “first” with respect to a feature or element doesnot necessarily imply the existence of a second or additional suchfeature or element. Elements recited in means-plus-function format areintended to be construed in accordance with 35 U.S.C. §112(f). It willbe apparent to those having skill in the art that changes may be made tothe details of the above-described embodiments without departing fromthe underlying principles set forth herein.

The phrases “connected to,” “coupled to,” and “in communication with”refer to any form of interaction between two or more entities, includingmechanical, electrical, magnetic, electromagnetic, fluid, and thermalinteraction. The phrase “fluid communication” refers to two or morefeatures that are connected such that a fluid within one feature is ableto pass into another feature. Moreover, as defined herein the term“substantially” means within +/- 20% of a target value, measurement, ordesired characteristic.

While specific embodiments and applications of the present disclosurehave been illustrated and described herein, it is to be understood thatthe scope of this disclosure is not limited to the precise configurationand components disclosed herein. Various modifications, changes, andvariations which will be apparent to those skilled in the art may bemade in the arrangement, operation, and details of the devices, systems,and methods disclosed herein.

What is claimed is:
 1. A bone fixation assembly comprising: an elongatefixation member comprising: a central longitudinal axis; a first portioncouplable within a first intramedullary canal of a first bone fragmentof a bone; a second portion couplable within a second intramedullarycanal of a second bone fragment of the bone to provide fixation of thesecond bone fragment relative to the first bone fragment; a firsttransverse passageway formed through the first portion of the elongatefixation member; and a second transverse passageway formed through thesecond portion of the elongate fixation member; and a flexibletensioning element couplable to the first and second portions of theelongate fixation member to secure the elongate fixation member to thebone, wherein: the first transverse passageway is configured to receivethe flexible tensioning element therethrough from a first directiontransverse to the central longitudinal axis of the elongate fixationmember; the second transverse passageway is configured to receive theflexible tensioning element therethrough from a second directiontransverse to the central longitudinal axis of the elongate fixationmember; and the flexible tensioning element is configured to span a bonefracture intermediate the first bone fragment and the second bonefragment to preload the bone fracture in compression to resist tensileforce imparted across the bone fracture, thereby maintaining fixation ofthe first bone fragment relative to the second bone fragment.
 2. Thebone fixation assembly of claim 1, wherein a first end of the flexibletensioning element is couplable with a second end of the flexibletensioning element to secure the elongate fixation member to the bone.3. The bone fixation assembly of claim 1, wherein the flexibletensioning element comprises: a first tension band couplable to thefirst portion of the elongate fixation member through the firsttransverse passageway; and a second tension band couplable to the secondportion of the elongate fixation member through the second transversepassageway.
 4. The bone fixation assembly of claim 3, wherein the firstand second tension bands are couplable to each other to secure theelongate fixation member to the bone.
 5. The bone fixation assembly ofclaim 4, wherein a first end of the first tension band is couplable witha second end of the second tension band, and a second end of the firsttension band is couplable with a first end of the second tension band toform a crisscross pattern that spans the bone fracture and secures theelongate fixation member to the bone.
 6. The bone fixation assembly ofclaim 1 comprising a securing element couplable to the flexibletensioning element and configured to prevent loosening of the flexibletensioning element.
 7. The bone fixation assembly of claim 1 comprisinga tensioner element couplable to the flexible tensioning element andconfigured to impart a tension force to the flexible tensioning element.8. A bone fixation assembly comprising: an elongate fixation membercomprising: a central longitudinal axis; a distal portion couplable to afirst bone fragment of a bone; and a proximal portion couplable to asecond bone fragment of the bone to provide fixation of the second bonefragment relative to the first bone fragment; and a flexible tensioningelement couplable to the proximal portion and the distal portion of theelongate fixation member to secure the elongate fixation member to thebone, wherein the flexible tensioning element is configured to span abone fracture intermediate the first bone fragment and the second bonefragment to preload the bone fracture in compression to resist tensileforce imparted across the bone fracture, thereby maintaining fixation ofthe first bone fragment relative to the second bone fragment.
 9. Thebone fixation assembly of claim 8, wherein a first end of the flexibletensioning element is couplable with a second end of the flexibletensioning element to secure the elongate fixation member to the bone.10. The bone fixation assembly of claim 8, wherein a surface of theelongate fixation member comprises one or more channels configured toreceive the flexible tensioning element therein to secure the elongatefixation member to the bone.
 11. The bone fixation assembly of claim 8,wherein the flexible tensioning element comprises: a first tension bandcouplable to the distal portion of the elongate fixation member; and asecond tension band couplable to the proximal portion of the elongatefixation member and to the first tension band to secure the elongatefixation member to the bone.
 12. The bone fixation assembly of claim 11,wherein the elongate fixation member comprises: a first transversepassageway formed through the distal portion of the elongate fixationmember, wherein the first transverse passageway is configured to receivethe first tension band therethrough from a first direction transverse tothe central longitudinal axis of the elongate fixation member; and asecond transverse passageway formed through the proximal portion of theelongate fixation member, wherein the second transverse passageway isconfigured to receive the second tension band therethrough from a seconddirection transverse to the central longitudinal axis of the elongatefixation member.
 13. The bone fixation assembly of claim 8, wherein theelongate fixation member comprises a longitudinal passageway configuredto receive the flexible tensioning element therethrough.
 14. The bonefixation assembly of claim 8 comprising a securing element couplable tothe flexible tensioning element and configured to prevent loosening ofthe flexible tensioning element.
 15. The bone fixation assembly of claim8 comprising a tensioner element couplable to the flexible tensioningelement and configured to impart a tension force to the flexibletensioning element.
 16. A method of fixing a first bone fragment of abone relative to a second bone fragment of the bone, the methodcomprising: forming one or more first bone tunnels in the first bonefragment; forming one or more second bone tunnels in the second bonefragment; coupling a first portion of an elongate fixation member to thefirst bone fragment; coupling a second portion of the elongate fixationmember to the second bone fragment to provide fixation of the secondbone fragment relative to the first bone fragment; passing a flexibletensioning element through the one or more first bone tunnels and theone or more second bone tunnels; coupling the flexible tensioningelement to the first portion of the elongate fixation member and thesecond portion of the elongate fixation member to secure the elongatefixation member to the bone; and spanning a bone fracture intermediatethe first bone fragment and the second bone fragment with the flexibletensioning element to preload the bone fracture in compression to resisttensile force imparted across the bone fracture, thereby maintainingfixation of the first bone fragment relative to the second bonefragment.
 17. The method of claim 16, wherein: forming the one or morefirst bone tunnels in the first bone fragment comprises at least one of:forming a first transverse bone tunnel in the first bone fragment; andforming a first longitudinal bone tunnel in a first intramedullary canalof the first bone fragment; and forming the one or more second bonetunnels in the second bone fragment comprises at least one of: forming asecond transverse bone tunnel in the second bone fragment; and forming asecond longitudinal bone tunnel in a second intramedullary canal of thesecond bone fragment.
 18. The method of claim 17, wherein: coupling thefirst portion of the elongate fixation member to the first bone fragmentcomprises coupling the first portion of the elongate fixation memberwithin the first intramedullary canal of the first bone fragment; andcoupling the second portion of the elongate fixation member to thesecond bone fragment comprises coupling the second portion of theelongate fixation member within the second intramedullary canal of thesecond bone fragment.
 19. The method of claim 16, wherein: coupling thefirst portion of the elongate fixation member to the first bone fragmentcomprises coupling the first portion of the elongate fixation member toa first surface of the first bone fragment; and coupling the secondportion of the elongate fixation member to the second bone fragmentcomprises coupling the second portion of the elongate fixation member toa second surface of the second bone fragment.
 20. The method of claim 16further comprising: coupling a first end of the flexible tensioningelement with a second end of the flexible tensioning element to securethe elongate fixation member to the bone.